BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO NRG CR TIBIAL BEARING INSERT TRIAL #9 12MM

    MDR report key: 3120499 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01719
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE RETURNED DEVICE WAS IN LIKE NEW CONDITION. CAREFUL EXAMINATION FOUND NO DAMAGE TO THE RETURNED DEVICE INSPECTION OF AN IMAGE PROVIDED BY THE REPORTING SITE NOTED A SMALL BLACK PARTICLE, WHICH IS POTENTIALLY THE REPORTED DEBRIS AS THE REPORTED DEVICE IS MANUFACTURED FROM BLACK MATERIAL. THE SOURCE OF THE POTENTIAL DEBRIS CANNOT BE CONFIRMED AS THE RETURNED DEVICE WAS UNDAMAGED. A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED AS THE FAILURE WAS NOT RELATED TO PATIENT FACTORS. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. THE REPORTED EVENT REGARDING DEBRIS FOUND DURING TRIAL REDUCTION INVOLVING A SCORPIO NRG TIBIAL INSERT TRIAL WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY AFTER THE INSERT TRIAL REDUCTION JUST BEFORE WASHING THE WOUND SMALL DEBRIS WAS IDENTIFIED INTO THE SOFT TISSUE. ALLEGEDLY, THE DEBRIS WAS EASY TO IDENTIFY WITH THE COLOR CODE OF THE TRIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY AFTER THE INSERT TRIAL REDUCTION JUST BEFORE WASHING THE WOUND SMALL DEBRIS WAS IDENTIFIED INTO THE SOFT TISSUE. ALLEGEDLY, THE DEBRIS WAS EASY TO IDENTIFY WITH THE COLOR CODE OF THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221651 SCORPIO NRG CR TIBIAL BEARING INSERT TRIAL #9 12MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH 13EDF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other